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The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients

Primary Purpose

Malocclusion, Compliance, Patient

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Reminders
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malocclusion focused on measuring Intraoral elastics

Eligibility Criteria

10 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Full fixed appliances with intraoral class II elastics full-time
  • Wearing class II elastics for between 6 weeks & 3 months
  • Have smartphone with calendar-type app

Exclusion Criteria:

  • Orthognathic surgery planned
  • Craniofacial disorders

Sites / Locations

  • Guy's HospitalRecruiting
  • King's College Hospital
  • Dentalcare Langley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study group

Control group

Arm Description

This group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics.

This group will receive their orthodontic treatment and elastics instructions as normal, without reminders.

Outcomes

Primary Outcome Measures

Change in number of elastics used and collected by the participant
Participants from both arms will collect their used elastics in a plastic bag provided, which will be collected at each recall appointment and counted.

Secondary Outcome Measures

Patient's self-reported duration of time spent wearing intraoral elastics
Participants will fill out duration journals between appointments, on which they tick boxes to record how many hours a day they have worn their elastics
Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship
Clinicians will record these occlusal measurements at each appointment
Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale
Clinicians will record whether they think the patient has been highly, somewhat, or not at all compliant

Full Information

First Posted
January 30, 2017
Last Updated
February 14, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03144323
Brief Title
The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients
Official Title
The Effectiveness of Electronic Reminders in Improving Intra-oral Elastic Compliance in Orthodontic Patients: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College Hospital NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Fixed orthodontic appliances in combination with intraoral elastics are a common and effective method use in the orthodontic correction of malocclusions. However, their success is largely dependent on the patient's compliance. Failure to wear the elastics as instructed will reduce efficacy of treatment, ultimately increasing treatment time and potentially producing imperfect alignment of teeth. The hypothesis tested is that daily electronic reminders via a mobile application can significantly increase patient compliance, thus effectively improving treatment outcomes.
Detailed Description
Despite advancements in various aspects of orthodontic treatment, patient compliance remains a critical factor in attaining a successful treatment outcome. More specifically, patient compliance in the use of intraoral elastics is an important component of the treatment plan of certain patients. Failure to wear elastics as directed will ultimately result in increased treatment time, and imperfect alignment of the teeth. Persuading adolescent orthodontic patients to wear intraoral elastics consistently is difficult in the short appointment times of a typical practice. Studies have shown that adolescents respond at a higher level to a more constant form of communication, as well as a method more closely associated with their generation. As smartphones have become an everyday appliance for most of the general public, mobile applications (apps) have the capability to serve as an effective avenue for communication between doctor and patient. Recent studies in both dentistry and medicine have reported that active reminders via mobile phone improve appointment attendance, adherence to medication schedules, and positive behaviour changes. The investigators will utilise the "Calendar" app to communicate via daily reminders with patients undergoing orthodontic treatment with fixed appliances and Class II intraoral elastics, and they will measure the improvement in the malocclusion. This will allow study of whether or not electronic reminders can significantly increase compliance. As more apps are developed, this communication method may have the potential to greatly impact the way orthodontists and patients interact outside of the office. If effective, these apps could become a cornerstone of the compliance efforts of many orthodontic practices. This would benefit both the orthodontist and the patient, as it would decrease time and money spent for both parties as well as reduce the overall sense of frustration felt during extended orthodontic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Compliance, Patient
Keywords
Intraoral elastics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
This group will receive 4 daily electronic reminders via the Calendar app on their mobile phones, reminding them to wear their elastics.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will receive their orthodontic treatment and elastics instructions as normal, without reminders.
Intervention Type
Behavioral
Intervention Name(s)
Reminders
Intervention Description
Four reminders will be set on the patient's mobile phone's Calendar-type app, saying "Don't forget to wear your elastics", at 08:00, 13:00, 17:00 and 22:00.
Primary Outcome Measure Information:
Title
Change in number of elastics used and collected by the participant
Description
Participants from both arms will collect their used elastics in a plastic bag provided, which will be collected at each recall appointment and counted.
Time Frame
6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Patient's self-reported duration of time spent wearing intraoral elastics
Description
Participants will fill out duration journals between appointments, on which they tick boxes to record how many hours a day they have worn their elastics
Time Frame
6 weeks and 12 weeks
Title
Change in participant's jaw relationship, measured on mm scale by difference in overbite, overjet and molar relationship
Description
Clinicians will record these occlusal measurements at each appointment
Time Frame
Baseline, 6 weeks, and 12 weeks
Title
Clinician-perceived level of compliance of the participant at each appointment, using discrete qualitative scale
Description
Clinicians will record whether they think the patient has been highly, somewhat, or not at all compliant
Time Frame
Baseline, 6 weeks, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Full fixed appliances with intraoral class II elastics full-time Wearing class II elastics for between 6 weeks & 3 months Have smartphone with calendar-type app Exclusion Criteria: Orthognathic surgery planned Craniofacial disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Bister
Phone
020 7188 4415
Email
dirk.bister@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jadbinder Seehra
Phone
07334870265
Email
jadbinder.seehra@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Bister
Organizational Affiliation
Guy's and St Thomas's Hospital NHS Foundation Trust
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jadbinder Seehra
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Bister
Email
dirk.bister@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Catherine Liu
Phone
07443870265
Email
catherine.liu@kcl.ac.uk
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadbinder Seehra
Email
jadbinder.seehra@nhs.net
First Name & Middle Initial & Last Name & Degree
Catherine Liu
Phone
07443870265
Email
catherine.liu@kcl.ac.uk
Facility Name
Dentalcare Langley
City
Slough
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jadbinder Seehra
Email
jadbinder.seehra@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectiveness of Electronic Reminders in Improving Elastic Compliance in Orthodontic Patients

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